Fractional Flow Reserve (FFR) Versus Instant Wave-Free Ratio (iFR)

NCT ID: NCT01559493

Last Updated: 2012-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-02-29

Brief Summary

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Comparison of Fractional Flow Reserve versus instant Wave-Free Ratio for assessment of coronary artery stenosis severity in routine practice

* To compare FFR to iFR in arbitrary consecutive patients referred for percutaneous coronary intervention (PCI).
* To investigate the influence of hyperemia on iFR.
* To test reproducibility of iFR and FFR.

Detailed Description

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Conditions

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Coronary Artery Disease Plaque, Atherosclerotic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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FFR; iFR

Interventional Cardiology, Pressure wire, fractional flow reserve, coronary flow measurement

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* all consecutive patients undergoing FFR assessment for standard clinical indications.

Exclusion Criteria

* prior CABG
* extremely tortuous, calcified lesions
* coronary artery occlusion
* acute MI within 5 days
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Golden Jubilee National Hospital

OTHER_GOV

Sponsor Role collaborator

Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role collaborator

Onze Lieve Vrouw Hospital

OTHER

Sponsor Role collaborator

Stockholm South General Hospital

OTHER

Sponsor Role collaborator

Brno University Hospital

OTHER

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role collaborator

NHS National Waiting Times Centre Board

OTHER

Sponsor Role lead

Responsible Party

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Prof. Keith G. Oldroyd

Consultant Cardiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Prof Keith G. Oldroyd

Role: PRINCIPAL_INVESTIGATOR

Golden Jubilee National Hospital

Prof Colin Berry, MD

Role: PRINCIPAL_INVESTIGATOR

Golden Jubilee National Hospital

Locations

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Stanford University

Stanford, California, United States

Site Status

Cardiovascular Center Aalst

Aalst, , Belgium

Site Status

University Hospital Brno

Brno, , Czechia

Site Status

Catharina Ziekenhuis

Eindhoven, , Netherlands

Site Status

Stockholm South Hospital

Stockholm, , Sweden

Site Status

Countries

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United States Belgium Czechia Netherlands Sweden

References

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Berry C, van 't Veer M, Witt N, Kala P, Bocek O, Pyxaras SA, McClure JD, Fearon WF, Barbato E, Tonino PA, De Bruyne B, Pijls NH, Oldroyd KG. VERIFY (VERification of Instantaneous Wave-Free Ratio and Fractional Flow Reserve for the Assessment of Coronary Artery Stenosis Severity in EverydaY Practice): a multicenter study in consecutive patients. J Am Coll Cardiol. 2013 Apr 2;61(13):1421-7. doi: 10.1016/j.jacc.2012.09.065. Epub 2013 Feb 6.

Reference Type DERIVED
PMID: 23395076 (View on PubMed)

Other Identifiers

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Version F 2nd Jan 2012

Identifier Type: -

Identifier Source: org_study_id

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